UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055366 |
|---|---|
| Receipt number | R000063273 |
| Scientific Title | Nutritional status of inflammatory bowel disease patients in clinical remission, prospective observational analysis |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/08/29 18:16:50 |
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Basic information
Public title
Nutritional status of inflammatory bowel disease patients
Acronym
Nutritional status of IBD patiets
Scientific Title
Nutritional status of inflammatory bowel disease patients in clinical remission, prospective observational analysis
Scientific Title:Acronym
Nutritional status of iBD in clinical remission, prospective analysis
Region
| Japan |
Condition
Condition
inflammatory bowel disease, ulcerative colitis and crohn's disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To revearl the causal relation of nutritional status among inflammatory bowel disease patients in clinical remission and their prognosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical remission in 52 week
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients diagnosed as IBD
patients in clinical remission more than 3 months
patients undertake colonoscopy
Key exclusion criteria
patients with clinical activity
patients refuse to enter the study
patients in admission
severe liver failure, Child-Pugh-C
severe renal failure rGFR<30
pregnant woman
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryusaku |
| Middle name | |
| Last name | Kusunoki |
Organization
Higashihiroshima Medical Center
Division name
Gastroenterology
Zip code
7390041
Address
513 Saizyo-cho, Zike, Higashihiroshima-city, Hiroshima, Japan
TEL
082-423-2176
ryusakukusunoki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryusaku |
| Middle name | |
| Last name | Kusunoki |
Organization
Higashihiroshima Medical Center
Division name
Gastroenterology
Zip code
7390041
Address
513 Saizyo-cho, Zike, Higashihiroshima-city, Hiroshima, Japan
TEL
082-423-2176
Homepage URL
ryusakukusunoki@yahoo.co.jp
Sponsor or person
Institute
Higashihiroshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
Higashihiroshima Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Higashihiroshima Medical Center
Address
513 Saizyo-cho, Zike, Higashihiroshima-city, Hiroshima, Japan
Tel
082-423-2176
ryusakukusunoki@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objectives of this study is IBD patients who undertake colonoscopy and prospectively observed.
Baseline nutritional state and following clinical and endoscopic activities are prospectively observed
Management information
Registered date
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063273
